bluebird bio, Inc.

Good day and thank you for standing by. Welcome to the Bluebird BIO second quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. We request to please limit your question to one question only. Please be advised that today's conference is being recorded. Now I would like to hand the conference over to your first speaker for today, Ms. Liz Pinkpack. Please go ahead.

Good morning, everyone, and thank you for joining today's call to discuss our second quarter results and associated business updates. The press release announcing these updates can be found on the investor relations section of our website. Before we begin, let me review our safe harbor statement. Today's discussion contains statements that are forward-looking under the Private Securities Litigation Reform Act of 1995 and including financial projections in addition to statements of the company's plans, expectations, or intentions regarding development of our clinical program. Such statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of risk factors that could cause actual results to differ materially from projected results. A description of these risks is contained in our filings with the SEC, which are available on the investor relations section of our website. www.bluebirdbio.com. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so even if our expectations change, except as required by law. You should not rely on these forward-looking statements as representing our expectations of any date subsequent to today. Today's agenda is as follows. Nick will make opening remarks, and then Andrew and Phil will review the updates associated with our severe genetic disease business. Then Chip will review Oncology News and share an update on the planned business separation. They will then be joined for Q&A by several additional members of the management team. With that, I'll turn it over to Nick.

Thanks, Liz. And thank you, everyone, for joining the call this morning. As we outlined in the press release this morning, we look forward to sharing the incredible progress we've made over the last seven months as we prepare to separate and launch two exciting companies early in the fourth quarter, Bluebird and 270. We'll also talk with you more about the clinical hold the FDA has placed on our CALD studies and the safety event associated with that hold. One thing I'll say on the split is one of my biggest worries with the decision was the potential impact on our people and the unique Bluebird culture. I'm happy to share that my worry has turned to excitement as the passion and commitment to the Y has only gotten stronger as we focus and channel the teams into the Bluebird and 270 missions. We may use different words going forward, but the deep blue DNA will continue to be a strong, humbling, and inspiring force. Our intent with the separation is to ensure that we optimize each business from top to bottom in order to deliver on the respective missions. In the next few minutes, I will share the progress we've made to ready ourselves for the approaching day one. There are a few items of particular note. During today's call, you will hear from Andrew, our post-split Bluebird CEO, that we made the hard but right call to focus our severe genetic disease business on the US. The current EU access and reimbursement environment is simply not ready to support and adopt one-time potentially curative innovative medicines. Andrew will share more. Next, the team will share the very recent emergence of an MDS diagnosis for a boy in our ALD study. Our hearts go out to this young man and his family. The FDA, out of abundance of caution, placed the CALD program on a clinical hold. We have discussed this new information on the CALD program at length with the investigators, external experts, and thought leaders. We all believe that the risk-benefit for patients with CALD remains positive. Pending resolution of the hold, we continue to plan to pursue a U.S. regulatory submission this year. Importantly, we believe that this event does not reflect upon the field of lentiviral-based gene therapy broadly and will have no impact on our Thal, Sickle, and Oncology programs, including our planned Thal and Sickle BLA submissions. Shifting gears, we are now seven months into our separation efforts, and our confidence has grown significantly that it was the right strategic and operational move. Most importantly, and to the credit of an unbelievably resilient and committed team, our foundation has only gotten stronger as we execute our plans. Our efforts have focused on four key areas that we know to be important to the task ahead. First, establish and tune the vision and strategy for each business. Second, double down in every way on the products and R&D capabilities that will create the impact for patients and, over time, create value for all stakeholders. Third, get the best people, leaders, and culture in place to execute with conviction. Finally, enable the businesses with a healthy financial runway and balance sheet. I'm pleased to say we've made huge progress on all four fronts and will be ready to launch two highly innovative companies at the beginning of the fourth quarter. On the vision and product front, we have made clear plans. We have clear plans in place with several near-term milestones. The SGD business under Andrew's leadership has made great progress staying on track with the THAL-US ELA filing and continuing to move forward CLD filing while making the tough but necessary call to focus the business in the U.S. 270 is shaping up even better than expected. The uptake of ABECMA has been tremendous, and our product engine efforts run deep, with the first two next-gen INDs coming soon. People on culture fronts. Teams are in place, fired up, and ready to go. All 1,000 birds have been sorted to their future homes in oncology and the SGD businesses. We continue to add to the team that has unprecedented bench-to-bedside experience in an incredibly complicated field. The leadership teams are operating independently with several more key senior executives and board members joining soon, so stay tuned to hear more news on that front. Lastly, on the financial picture, we've been busy ensuring we have the right-sized operational plans, as well as the strong starting cash positions. Chip will share more, but here are the take-homes. We have systematically reshaped our cost structure over the last 12 months to eliminate approximately $400 million in cumulative expenses, unlocking runway. In the past two weeks, we've pulled some levers which further reshape and streamline our cost structure. Collectively, we expect these efforts and existing and emerging sources of revenue will allow us to launch each business with approximately 24 months, two years, of runway following the separation. In short, we're ready and excited for the approaching launch. Despite the challenges of the pandemic and the extra work in navigating separation, each business is not only delivering consistently on their respective products and pipelines, but also now supported by a strong and enabling financial foundation. With that, I will now pass it over to Andrew to share some more thoughts on Bluebird slash SGD front. Andrew.